Antimicrobial
Resistance (AMR) is recognised by the World Health Organisation (WHO)[1]
as an urgent global health priority affecting humans, animal health and
agriculture; resulting in the organisation putting together a global action
plan in 2015.

NSW-based company SpeeDx, along with key collaborators such as Melbourne Sexual Health and Royal Women's Hospital, Royal Brisbane Hospital and NSW Health Pathology; is tackling AMR head-on by developing diagnostics that can detect infectious diseases and markers for antibiotic resistance. The test is called ResistancePlus® and currently targets sexually transmitted infections (STIs) that have the potential to become the first incurable bacterial infections.

SpeeDx’s ResistancePlus® tests are rapid molecular diagnostics that
identify the infecting organism as well as the resistance status of the infection;
and can uniquely screen for the multiple and often complex genetic mutations
that are linked to AMR. The test combines a diagnostic approach that supports
resistance guided therapy, empowering clinicians to make informed treatment decisions.
Resistance guided therapy leads to faster and more effective cure rates for
patients, ensuring appropriate and effective treatment while working to minimise
the spread of AMR and improve antibiotic stewardship of existing treatment
options.

The ResistancePlus® MG test detects Mycoplasma
genitalium (Mgen) and five mutations linked with resistance to the
frontline treatment Azithromycin. Early-access laboratories have seen positive
results when using ResistancePlus MG to guide treatment options, identifying
resistant infections and ensuring the right antibiotic is prescribed, this has
improved overall cure rates for patients and lessened the risk of complications
from long-term infections.

CEO
of SpeeDx Colin Denver explained that seeking collaborators was the key to
advancing their technology forward.

“In order to develop diagnostic tests
that have true utility, SpeeDx has established strong relationships with
physicians and clinicians on the front-line,” Mr Denver said.

“Our unique technology advantage
coupled with our focused Australian research and manufacturing teams allows us
to rapidly respond to market needs.”

SpeeDx’s work with antimicrobial resistance is aligned with MTPConnect’s 10-year Sector Competitiveness Plan (SCP), linked to key megatrends and
knowledge priority areas identified as future areas of need. The project is
also fostering a highly collaborative environment for accelerating
commercialisation. SpeeDx
engages with key clinicians and leading researchers around the world including
Australia, the UK, and the US, to identify areas of clinical diagnostic need.

SpeeDx recognises that there can be challenges related to market education
as well as the public’s limited knowledge when developing market-leading tests.
Work to address these challenges includes raising awareness on how best to
incorporate the innovative technology into laboratory test menus in addition to
supporting key research and publications in relevant areas.

ResistancePlus® MG tests allow STI clinics
to gain upfront AMR information and improve patient care, and now STI management
guidelines around the world are being updated to include recommendations for
resistance testing to better manage the rise of AMR in Mgen. Melbourne Sexual
Health have reported that since using resistance guided therapy they have
increased overall cure rates of Mgen infections from 60% to over 92%[2].

SpeeDx
has identified the next target for ResistancePlus® to treat the
growing threat of AMR in gonorrhea infections. The ResistancePlus GC test will
identify infections susceptible to ciprofloxacin, an older antibiotic that
could be used in place of existing frontline treatments. SpeeDx’s unique
pipeline of ResistancePlus® tests provide the individualised
information needed by infectious disease clinicians in Australia and around the
world, helping them to combat AMR and improve antibiotic stewardship.

ResistancePlus MG is now being used in over 80% of Australian laboratories
and multiple countries throughout Europe, with clinical trials underway in the
U.S. in preparation for FDA submission later this year.